Prime Highlights:
Pfizer UK, a subsidiary of Pfizer, has introduced a new therapeutic agent, sotatercept, branded as Winrevair, following its approval by the UK’s Medicines and Healthcare products Regulatory Agency for the treatment of pulmonary arterial hypertension (PAH).
The drug was acquired in 2021 through Pfizer’s $11.5 billion acquisition of Acceleron Pharma, significantly expanding the company’s cardiovascular drug portfolio.
In clinical trials, sotatercept demonstrated superior efficacy over placebo in improving exercise capacity among 323 PAH patients.
Key Background:
Merck & Co., a leading U.S. pharmaceutical company, announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its treatment, sotatercept, for the management of pulmonary arterial hypertension (PAH), a rare and life-threatening lung disease. Branded as Winrevair, the drug was acquired by Merck through its $11.5 billion purchase of Acceleron Pharma in 2021. The approval marks another success in Merck’s expanding cardiovascular portfolio, which is critical as the company faces potential sales declines due to patent expirations, including for its top-selling cancer drug, Keytruda.
Sotatercept has been approved for use in adults with moderate to severe limitations in physical activity due to PAH. This condition, characterized by elevated blood pressure in the pulmonary arteries, forces the heart to work harder and can lead to heart failure if untreated. In a clinical trial involving 323 patients, sotatercept demonstrated a significant improvement in exercise capacity, positioning it as a promising treatment for this challenging disease. The therapy targets activin, a protein that contributes to the constriction of lung arteries.
Having already received approval in the United States in March 2024, sotatercept has also been authorized for sale in the European Union and 30 other countries. The MHRA’s endorsement makes the UK the third country to approve the drug. Sotatercept is administered as a self-injection every three weeks, facilitating the management of PAH as a chronic condition.
Since its commercial launch in March 2024, Winrevair has generated $149 million in sales. Analysts anticipate that the drug will exceed $1 billion in sales by 2025. In the UK, there were 9,263 active PAH patients recorded by the National Health Service (NHS) as of last March, representing a significant market for the treatment. While Merck has not disclosed pricing details for the UK, the drug is priced at approximately $14,000 per vial in the U.S. With the approval of sotatercept, Merck continues to strengthen its cardiovascular business, a key element of its strategy to diversify its portfolio beyond oncology.
